Optimizing Response in Psychosis Study

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder Not Otherwise Specified

Intervention: long-acting injectable risperidone (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: North Shore Long Island Jewish Health System

Official(s) and/or principal investigator(s):
Delbert G Robinson, M.D., Principal Investigator, Affiliation: The North Shore-Long Island Jewish Health System

The purpose of this project is to evaluate the efficacy of long-acting risperidone for patients with first episode schizophrenia spectrum who did not improve sufficiently with the first antipsychotic medication they tried during their initial treatment trial.

Official title: Optimizing Response in Psychosis Study

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Treatment Response Based Upon BPRS and CGI Ratings

Side Effects Based Upon Rating Instruments and Lab Tests

Patient Acceptance of Injections

Secondary outcome: Negative Symptoms

Detailed description: The goal of the proposed pilot study is to investigate the feasibility and efficacy of the long-acting injectable form of the second generation antipsychotic, risperidone, for the treatment of first episode patients who fail to respond to 12 weeks of treatment with an oral antipsychotic. The rationale for using this long-acting medication is that it eliminates covert non-adherence, which may be a factor in poor response. In addition, pharmacokinetic and pharmacodynamic differences between injectable and oral formulations may result in differences in treatment response favoring the injectable form. Subjects who have not responded sufficiently to treatment with an antipsychotic will be approached for the proposed long-acting risperidone trial. Risperidone treatment will be open label with titration based upon individual response (within FDA approved dose ranges). Treatment will begin with a phase of supplementation with oral risperidone. Subjects will stop their previous antipsychotic, start 2 mg of oral risperidone per day for one day and then increase the dose to 4 mg per day. Subjects who tolerate one week of oral risperidone will then begin injections of 25 mg long-acting risperidone every 2 weeks for a total of 12 weeks. If clinically indicated, the dose may be increased up to a maximum of 50 mg as per FDA guidelines.

Minimum age: 15 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Current DSM-IV-defined diagnosis of schizophrenia, schizophreniform disorder,

schizoaffective disorder, or psychotic disorder NOS as assessed using the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First et al, 1998)

- Is in the first episode of illness. First episode is defined as having had 6 months

or less of lifetime treatment with an antipsychotic.

- Has not responded sufficiently to treatment with an antipsychotic. Lack of response

is defined as a rating at study entry of 4 (moderate) or more on at least one of the following BPRS-A items: conceptual disorganization, grandiosity, hallucinatory behavior, unusual thought content.

- Continuous antipsychotic treatment at the time of study entry of a minimum of 12

weeks with the same antipsychotic agent.

- Antipsychotic dosing at some point during the 12 weeks must have reached a sufficient

dose for antipsychotic response (e. g. patients who received only low dose quetiapine for insomnia or anxiety would not qualify). Sufficient dose for second generation antipsychotics is defined as a minimum dose of risperidone 3 mg/day, olanzapine 10 mg/day, quetiapine 500 mg/day, ziprasidone 100 mg/day or aripiprazole 15 mg/day. Sufficient dose for first generation antipsychotics is defined as 3 mg/day of haloperidol or its equivalent for other first generation agents.

- Aged 15 to 40.

- If age 18 or older, competent and willing to sign informed consent.

- If under age 18, parent or guardian consent and subject assent.

- For women, a negative urine pregnancy test and agreement to use a medically accepted

method of birth control. Exclusion criteria:

- Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic

disorder due to a general medical condition, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features.

- Persistence of psychotic symptoms due to nonadherence to antipsychotic medication.

- Medical contraindications to treatment with long-acting injectable risperidone.

- Serious neurological or endocrine disorder or medical condition /treatment known to

affect the brain.

- A medical condition requiring medication with psychotropic effects.

- Clinical assessment that trial participation is contraindicated due to risk for

homicidal or suicidal behavior.

- A diagnosis of diabetes (fasting glucose > 126 mg/dl).

- Requires with antidepressant or mood stabilizing medication.

- Previous treatment with a long acting formulation of an antipsychotic

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

The Zucker Hillside Hospital, Glen Oaks, New York 11004, United States

web site of NARSAD

Starting date: April 2006
Last updated: June 10, 2015